Pharma Companies Try 'DRM' For Drugs As A Ploy To Stymie Generics

from the just-can't-give-it-up dept

One of the striking features of the drug world is how pharma companies become noticeably more inventive immediately before their patents are due to run out and their drugs are about to enter the public domain. That's because they need to find a way to differentiate themselves from the generic manufacturers that are then able to offer the same medicines for often vastly lower prices.

Usually this takes the form of modifying the formula of a drug slightly, patenting it, and then seeking to convince the medical profession that the new formulation is better in some way. But sometimes it involves more novel approaches, as here:

In coming months, generic drug producers are expected to introduce cheaper versions of OxyContin and Opana, two long-acting narcotic painkillers, or opioids, that are widely abused.

But in hopes of delaying the move to generics, the makers of the brand name drugs, Purdue Pharma and Endo Pharmaceuticals, have introduced versions that are more resistant to crushing or melting, techniques abusers use to release the pills' narcotic payloads.

As the New York Times article quoted above reports, having introduced these "tamper-resistant" designs, the pharma companies are now pushing to get a ban on generic versions that lack this feature. If you think of "tamper-resistant" techniques as a kind of DRM for drugs, the pharma companies are effectively asking for their own version of the DMCA, which forbids the circumvention of DRM.

The drug companies have dressed this up as a service to society, but some aren't buying it:

While companies like Purdue Pharma insist the public's health is their main concern, others note that producers introduced tamper-resistant versions of their products just as the drugs were about to lose patent protection. In court papers filed in response to Endo’s lawsuit, the F.D.A. described the company's action as a "thinly veiled attempt to maintain its market share and block generic competition."

according to a Washington Post examination of key scientific papers, a court document and FDA records, many of those claims [about minimal risks] were developed in studies supported by Purdue Pharma, the maker of OxyContin, or other drug manufacturers. In addition, the conclusions they reached were sometimes unsupported by the data, and when the FDA was struggling to come up with an opioid policy, it turned to a panel populated by doctors who had financial relationships with Purdue and other drugmakers.

So it would seem that rather than mandating the use of tamper-resistant packaging for these kinds of painkillers, a better long-term solution would be to avoid the use of these drugs altogether, where possible.

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When you try to crush it, it turns to powder.

I'm on a long-term pain management plan and narcs are part of it. I *hate* taking them and try to cut the pill in half so I don't have to take the whole thing. I've had a couple of different tablets that, when placed in the pill cutter, get pulverized. The last thing anyone wants it a mouth full of bitter powder.

A glowing example of abuse of patents coupled to abuse of the regulatory system to protect a companies monopoly. I expect that the new formulation is obvious, as in general the mechanical properties of the pill have little to do with the active content, and much to do with the inert fillers and binders. If they get away with this, expect them to repeat the trick on the next drug to fall out of patent.

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I think you can brace for a period of patenting relating to mechanical properties. The capsules only breaking in the stomach is just the beginning. Next thing will be sugar-coating to cross the blood brain barrier and after that, well, let us just say that timed releases in the body is a way to improve the effect of the active content significantly. That we are dealing with mechanics instead of compounds would seem insignificant.

Now, the abuse is smarter than that: You make a discovery get a patent on only the core properties. When it runs out you "improve" the patented technology by adding just enough of the properties you already know to make the improvements significant. You might get a free patent or two by being selective with the papers you put out. But the competitors? Well, unless it was a directly competitive invention process you can easily do this since no competitors would be stupid enough to invent from a knowledge disadvantage. Ironically 5 years is far too short a period for inventing from behind to be a realistic business model and it takes some seriously effective shortcuts in the processes to even think of such a praxis in a 20 year regime.

What they abuse is a hole in the way economics work: Patents are said to improve scientific output, which is true when everybody knows everything. The problem is that nobody read 10000 patents each year to keep up with the development just as well as reproducing results from patents is a significant cost for competitors. Therefore niche science and improvement on your own patents are the ways to go in this field. Niche science will often get shot down by the economic steps in the process if they are too far from the big markets. The only true way to abuse this part of the system is by stepwise patenting. It is cheap and disgusting, but it works!

There's a bunch of drugs coming up that the patents are coming to and end on. Among the ideas big pharma has come up with is asking doctors to only subscribe their products with a return on sales...read that as kick back. Then there is the wanting of striking a deal with the generic companies to increase their charges on drugs. And the request to pharmacies that they will match the price of the generics if the pharmacies will recommend theirs over the generic.

If you get to watching, in the last years before the patent runs out these drug companies will increase the cost of the drug to the patients, running the price up as much as they dare.

Re: But of Course

How simplistic of you...you deep thinker you.

The company requires the big Govt to pass a DMCA for drugs, thus Big Govt is the problem.

The big Govt installed the current fucked up "protection" systems (copy write, patents, etc). Competition (Capitalism) is the key to getting these drug makers to be more innovative and less protectionists.

“If you think of "tamper-resistant" techniques as a kind of DRM for drugs, the pharma companies are effectively asking for their own version of the DMCA, which forbids the circumvention of DRM.”
Govt initiates the protection and asks for bribes (contributions) for a quid pro quo all day long, every day.

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OxyContin's supposed to be an extended time release formula, over 12 hours. What has happened is that addicts crush the drug up and take it all at once to get one major dose of the drug, instead of a dribble of medicine over 12 hours. So done properly (the body still dissolves it gradually) it wouldn't have any effect on people taking it properly, but would make it harder for addicts to get their fix.

Pharma companies...

are all about making the most money possible, NOT about curing disease or improving people's lives. If they could make $ 10 million saving 100,000 lives OR 8 million saving 1,000,000 lives, they would definitely choose to make $ 10 million since that is what their their stockholders demand. Profit rules.

Re: But of Course

Re: Re: Patents increase innovation

Capitalism would agree with you...Govt has driven the protectionist agenda with a fury-
Giving patents that should have NEVER been given in the first place while pushing protectionism with specialized courts and extending copy write to a ridiculously long time.

Maybe if the companies seeking protectionism didn't seek to cover the good with the bad, there could be an innovation boom. OxyContin and Opana have helped people and now they want to apply “protectionism” to artificially extend the patents.

List of the "supposed" Good Guys that are "easier" to control than Corporations:
UN
EU
UK
USA
Oz
CA
The list is endless, filled with moronic GOVT pukes that FU things that don't need to any interference.

What should be done.

The gov should ban non tamper-resistant versions, then seize the patents "For the Public Good" and give manufacturers (generics and primary) free licenses. (This is all dependent on the patent actually does make it difficult to abuse the drug.)

Re: Re: Re: But of Course

protip: corps ARE already directly government related
they exist, and the evil they do is solely based on the legal fiction that save shareholders from the actions of the ceo and save the ceo from his actions that the shareholders "forced" him to do

Crocodile Tears

FWIW, Purdue Pharma _refused_ to add such a blocker when sued/supplicated by the Commonwealth of Kentucky, often the nation's leading per capita abuser of Oxycontin...now that they might have a dollar impact, losing the legions of addicts they've created, they want to bar the door on others making that money.

Insidious.

Further, the mental health professionals I know that serve in the opiate trenches have little faith that addicts cannot learn adequate chemistry skills to defeat such blockers, as they already have with similar addictive medications. While still worth doing, but don't be surprised that pharmacological DRM is no more effective than software DRM.

Re: Re: Pharma companies...

What an amazing insight, may I ask what have YOU done in order to feel in such a position to order people around like that?

And that secondly, if we were to talk about doing what is right, the people who would earn the highest salaries would be the doctors and researchers rather than some stock holder who sits in his chair 8 hours a day looking at a graph and making money out of thin air.

The financial sector reaps the profits of every other sector to themselves, and while doing that, demands that this must be the case or else there wont be any money invested in the first place.

Finaly, when was the last time a banker(or investor) actualy helped salved a life again?

The point is the profit motive is the most important motive for a large corporation, and one of the places this is very obvious is in Big Pharma.

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So it would seem that rather than mandating the use of tamper-resistant packaging for these kinds of painkillers, a better long-term solution would be to avoid the use of these drugs altogether, where possible.

Mike, Mike, Mike. (!!!) Showing our Communist colors, are we?

ahem, trolling apart that's not in the best interests of the big pharma pockets, is it? In the end they couldn't care less if people are addicted or if millions are dying because they can't afford the cheer expensive medicine they sell, it's all about profit. They will, however, try to keep that incredible greed under a disguise that will suffice for people not to be outraged and backlash at their abusive practices.

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'Big government' is just a paid shill for 'Big corps'. You'd have a half a point if you allowed for your corporate Randian overlords being less than perfect, but no, selfish self-interest MUST win over any form of altruism or enlightened self-interest.

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The way it was, they could crush it, dissolve it and inject with needle.

The "new" pill gels when you try to do this. It has been here in Canada for a bit.

Supposedly, I heard from an old high school friend, another old high school acquaintance of ours, had a way around this in one week. He supposedly sells this method for a percentage of your prescription.

Isn't it odd that the drug was safe for 12 years, then we have so many addicts this drug is no longer safe IN ITS CURRENT FORM, but safe in another form?

How did we get so many addicts? Where are the news reports of these facilities being broken into and millions upon millions of these pills being stolen?

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Re: Re: Pharma companies...

LoL

Did you read the news about how superbugs are becoming unstoppable and big pharma companies only care about anti-baldness and erection sustaining pills?

If I am not mistaken even one of the big international bodies came out and outright said it, that drug patents failed to improve vital life saving drug research and they were calling others to invest in open source initiatives, now that is desperate.

Congress recognized the problem earlier this year, inserting a provision in an FDA authorization bill to grant an additional five years of market exclusivity — meaning no competition from generics — for companies inventing new antibiotics.

“It’s a great first step,” said Spellberg, but he added that the provision “is not strong enough to turn things around.”

Re: Re: Re: Pharma companies...

What?? The following statement was in question.“Pharma companies...are all about making the most money possible, NOT about curing disease or improving people's lives.”
Nothing demonstrated to back that opinion.

Your financial sector "argument"/sarc is about capital that backs everything we do. Without capital, we limit our discoveries and our life styles.

Where do you think Your pension/retirement fund is invested? Yes, companies like big pharma. YOU and your ilk are funding these companies by investing in them through your retirement account.

I just suggested that the poster use something like Kickstarter to fund his own "life saving" drug. Or would that be too hard? Oh yea, the poster doesn't have someone sending money via a retirement acct so they can do research.

Re: Re: Re: Pharma companies...

So if big pharma is out, where do we get the cure? Are you going to do it? I'm not, how about one someone in your family? Use Kickstarter to fund research for the “bugs” you talk about. Solution anyone?

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No, we're saying that the corporations are the government for all real purposes. Laws aren't passed for the public, they're passed for the corporate good. All your railing about 'Big Government' is still railing against corporate greed.

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Re: Re: Re: Re: Pharma companies...

Ooooh! So close, then you had to make your own invalid and unsupported assumptions. It's long been acknowledged that we do not look for cures, we look for treatments. Treatments pay the bills while cures would quickly put them out of business. Don't bother asking what I've done to save people. That is just a distraction, and irrelevant to the discussion.